An overview of conventional aseptic processing is presented and it addresses the key issues that corporate decision makers are faced with when implementing isolation technology, such as regulatory requirements and equipment validation focus areas.

This presentation given by Dr. Carmen Wagner reviewed the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey, coordinated with the assistance of Ms. Jennifer Raynor of Serentec, confirmed that sterility testing in isolators is now the "norm" vs. being a novelty. One key finding of the survey was that these systems have been predominantly placed in unclassified, although controlled access, areas.